Raheleh Ganjali1, Zhila Taherzadeh2,3, Mahin Ghorban Sabbagh4,5, Fatemeh Nazemiyan4,5, Fereshteh Mamdouhi4,5, Hamed Tabesh1, Shapour Badiee Aval6, Reza Golmakani7, Sayyed Mostafa Mostafavi1, Saeid Eslami1,8,9. 1. Department of Medical Informatics, Faculty of Medicine. 2. Neurogenic Inflammation Research Center. 3. Targeted Drug Delivery Research Center. 4. Kidney Transplantation Complications Research Center. 5. Department of Nephrology, Faculty of Medicine. 6. Complementary Medicine Research Center, Faculty of Traditional Medicine. 7. Department of Emergency Medicine, Doctor Shariati Hospital. 8. Pharmaceutical Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. 9. Department of Medical Informatics, University of Amsterdam, Amsterdam, The Netherlands.
Abstract
INTRODUCTION: Adherence to a complex and ongoing set of therapeutic recommendations significantly determines short and long-term outcomes after kidney transplantation (KT). Interactive voice response system (IVRS) is a novel phone-based platform which is potentially useful to deliver health behavior interventions. OBJECTIVE: The aims of the study is to describe the development of a theory-driven and educational IVRS investigate the effect of an IVRS on the self-management outcomes in KT recipients as compared with the control group. METHODS: This study has been designed as a randomized, 2 parallel groups controlled trial. The KT recipients' older than18 years of age with access to a cellphone will be included. A total of 120 patients will be randomly assigned to the control and intervention groups. The participants in the intervention group will receive completely automatic calls in 3 categories: educational, medication adherence, and reminders by the IVRS, whereas those in the control group will receive usual care. The follow up will be performed within 6 months. The primary outcome will be the medication adherence while patients' transplant knowledge, health-related quality of life, and rehospitalization rates will be considered as secondary outcomes. RESULTS: Thus far, recruitment of participants has not been completed and results will be published in 2019. DISCUSSION: The IVRS is potentially useful to help KT recipients improve the self-management outcomes. The hypothesis is using an IVRS intervention makes a significant difference between basel assessment of adherence to immunosuppressive medications scale, 12-item short form survey, second version, kidney transplant understanding tool baseline scores, and those obtained at the end of study. TRIAL REGISTRATION NUMBER: This trial is registered with the Iran Trial Registrar under registration number IRCT20180124038492N1 and registration date 30 January 2018. https://irct.ir/trial/29215.
RCT Entities:
INTRODUCTION: Adherence to a complex and ongoing set of therapeutic recommendations significantly determines short and long-term outcomes after kidney transplantation (KT). Interactive voice response system (IVRS) is a novel phone-based platform which is potentially useful to deliver health behavior interventions. OBJECTIVE: The aims of the study is to describe the development of a theory-driven and educational IVRS investigate the effect of an IVRS on the self-management outcomes in KT recipients as compared with the control group. METHODS: This study has been designed as a randomized, 2 parallel groups controlled trial. The KT recipients' older than18 years of age with access to a cellphone will be included. A total of 120 patients will be randomly assigned to the control and intervention groups. The participants in the intervention group will receive completely automatic calls in 3 categories: educational, medication adherence, and reminders by the IVRS, whereas those in the control group will receive usual care. The follow up will be performed within 6 months. The primary outcome will be the medication adherence while patients' transplant knowledge, health-related quality of life, and rehospitalization rates will be considered as secondary outcomes. RESULTS: Thus far, recruitment of participants has not been completed and results will be published in 2019. DISCUSSION: The IVRS is potentially useful to help KT recipients improve the self-management outcomes. The hypothesis is using an IVRS intervention makes a significant difference between basel assessment of adherence to immunosuppressive medications scale, 12-item short form survey, second version, kidney transplant understanding tool baseline scores, and those obtained at the end of study. TRIAL REGISTRATION NUMBER: This trial is registered with the Iran Trial Registrar under registration number IRCT20180124038492N1 and registration date 30 January 2018. https://irct.ir/trial/29215.
Authors: Elisa J Gordon; Thomas Prohaska; Laura A Siminoff; Peter J Minich; Ashwini R Sehgal Journal: Am J Kidney Dis Date: 2005-05 Impact factor: 8.860
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Authors: B W Pinsky; S K Takemoto; K L Lentine; T E Burroughs; M A Schnitzler; P R Salvalaggio Journal: Am J Transplant Date: 2009-11 Impact factor: 8.086
Authors: Lisa Mellon; Frank Doyle; Anne Hickey; Kenneth D Ward; Declan G de Freitas; P Aiden McCormick; Oisin O'Connell; Peter Conlon Journal: Cochrane Database Syst Rev Date: 2022-09-12